Routine vs Selective Cardiac Magnetic Resonance in Non-Ischemic Heart Failure (OUTSMART-HF) Project I-B of Imaging Modalities to Assist With Guiding Therapy and the Evaluation of Patients With Heart Failure (IMAGE-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 15
- 主要终点
- Frequency of definitive diagnoses
研究概览
简要总结
Uncovering the underlying cause of heart failure can be quite challenging and doctors often rely on imaging tests such as echo (heart ultrasound) to provide the answers. Cardiac MRI is emerging as another promising test because it gives very precise information on heart function and the amount of scarring in the muscle. Heart failure patients are increasingly being sent for cardiac MRI but the potential advantage that this test offers over others such as echo has not been fully explored.
The purpose of this study is to determine if cardiac MRI provides more information on the cause of heart failure than traditional tests such as echo. In addition, if the information provided by this test always leads to an overall improvement in a patient's heart condition over time.
This is a randomized study where subjects referred for clinically indicated heart failure workup to determine the best clinical management will undergo standard heart failure testing (including echo) OR standard testing PLUS cardiac MRI.
详细描述
Primary objective: to compare the effect of routine cardiac magnetic resonance (CMR) versus standard care (i.e. echocardiography with only selective use of CMR) on the etiological diagnosis in patients with a non-ischemic heart failure (HF). The proposed categories of HF to be considered in this study include: idiopathic dilated cardiomyopathy, infiltrative cardiomyopathy, inflammatory, hypertrophic cardiomyopathy, heart failure with preserved ejection fraction (HFPEF), ischemic cardiomyopathy, mixed etiology and other (eg. pericardial, congenital, non-compaction, right ventricular failure).
Primary hypothesis: Routine use of CMR (vs. selective use) will lead to a more specific diagnostic characterization of the underlying etiology of non-ischemic heart failure. This will lead to a reduction in the diagnosis of idiopathic dilated cardiomyopathy and HFPEF.
Secondary objectives: Determine the effects that routine use of CMR in non-ischemic HF has on therapeutic decisions, on the Composite Clinical Endpoint (CCE), cardiac function, symptoms, quality of life (QoL), and costs. Ancillary measurements will include the safety of imaging tests and adverse reactions to gadolinium contrast agent.
Secondary hypothesis: Routine use of CMR will have significant impact on treatment decisions, (1) lead to more disease specific therapies and/or (2) cause a significant change in the number and class of HF meds, during follow-up. The routine CMR group will also have improved clinical outcomes (CCE), symptoms and QoL and decreased costs to the standard of care group during follow-up.
Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with new or worsening HF as above AND
- •Working clinical diagnosis (known or highly suspected) of non-ischemic cardiomyopathy (NICM) OR Clinical diagnosis of HFPEF (Signs or symptoms of heart failure with a LVEF ≥ 40%)
- •Documented history of Class II-IV NYHA HF symptoms within the past 12 months
排除标准
- •Prior CMR and no major change in clinical condition
- •Well-documented specific etiology (eg known amyloidosis or hemochromatosis)
- •MD considers cause of heart failure is attributable to obstructive CAD.
- •Documented previous STEMI (any territory) or NSTEMI in LAD territory
- •Severe medical conditions that significantly affect the patient's outcome (eg. active malignancy)
- •Ongoing need for advanced cardiac life support (eg IABP)
- •Severe valvular heart disease requiring surgery within the next 6 months
- •Contraindications to CMR (e.g. certain metallic implants, severe claustrophobia)
- •Contraindications to gadolinium contrast agent (GFR < 30ml/min/1,72m2, pregnancy)
- •Inability to give informed consent
- •Evidence of multivessel ischemia on stress imaging
结局指标
主要结局
Frequency of definitive diagnoses
时间窗: 3 and 12 months
Following the completion of all baseline testing (including echo) in the selective arm and baseline testing + CMR in the routine arm, the treating physician will assign a diagnosis on a standardized template using all available information. The diagnosis of non-ischemic cardiomyopathies will be based upon recent Canadian Consensus Statement. Expected Result - The routine CMR group will have a significantly higher rate of specific diagnoses for (a) heart failure with preserved systolic function (HFPSF) and (b) dilated cardiomyopathy (DCM) diagnoses (i.e. fewer idiopathic DCM) than the selective CMR group.
次要结局
- Resource utilization and costs(3 and 12 months)
- Echo/CMR variability:(baseline)
- HF Diagnosis Variability:(3 and 12 months)
- Treatment effects(3 and 12 months)
- Clinical Endpoints(3 and 12 months)
研究者
Rob Beanlands
Rob S. Beanlands, MD, FRCPC, Chief of Cardiology
Ottawa Heart Institute Research Corporation